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510(k) K821383

ECHO, MODEL MM-1000 by Mesa Medical, Inc. — Product Code LIF

K821383 is an FDA 510(k) premarket notification submitted by Mesa Medical, Inc. for the device "ECHO, MODEL MM-1000". The FDA issued a decision of Substantially Equivalent on June 23, 1982. The device falls under product code LIF (Dialyzer Reprocessing System), a Class II device regulated under 21 CFR 876.5820. Mesa Medical, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 1982
Date Received
May 10, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer Reprocessing System
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Mesa Medical, Inc.

  • K925210 — 90DX MULTITEST METER, MODIFICATION (January 25, 1994)
  • K882032 — MODEL 90DX MULTITEST METER (August 11, 1988)
  • K870811 — MODEL 102 PH METER (March 24, 1987)
  • K852749 — RECOMMENDED ALTERNATIVE DIALYZER DISINFECTANT (September 10, 1985)
  • K843520 — WAREXIN RECOMMENDED ALTERNATIVE DIALYZ (October 4, 1984)
  • K834447 — ECHO MM1000 (March 23, 1984)

Other clearances for product code LIF

  • K091360 — CLEARFLUX DIALYZER REPROCESSING SYSTEM (November 3, 2010)
  • K043126 — ASSIST HEADER CLEANER (February 3, 2005)
  • K040660 — STERICHEK GLUTARALDEHYDE REAGENT STRIPS (November 15, 2004)
  • K033505 — RENACLEAN SH DIALYZER CLEANING SYSTEM (April 27, 2004)
  • K024076 — MAKY 21.1 DIALYZER REPROCESSING SYSTEM (September 26, 2003)
  • K013713 — ARM AUTOMATIC REPROCESSING MACHINE (July 15, 2002)
  • K992016 — AMUKIN D (January 10, 2000)
  • K991851 — RENACLEAR DIALYZER CLEANING SYSTEM (August 30, 1999)
  • K974426 — POTENCY TEST STRIPS, INDICATOR TEST STRIPS (February 10, 1999)
  • K974798 — STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS (March 20, 1998)

FDA data resources